Proposed Rule 29 May 2025 regulatory compliance, reporting and recordkeeping requirements, business impact, security measures, harbors, coast guard, waterways, marine safety, navigation (water), safety zone, cincinnati, ohio river

🚤Proposed Safety Zone Impacting Businesses on Ohio and Licking Rivers

The Coast Guard is proposing to establish a temporary safety zone from Mile Marker 469.5-Mile Marker 470.5 of the Ohio River and from Mile Marker 0.0-Mile Marker 0.3 of the Licking River. This action is necessary to provide for the safety of life on these navigable waters near Cincinnati, OH, during the Red Bull Flugtag sporting event occurring on August 9, 2025. This safety zone prohibits persons and vessels from transiting through the safety zone unless authorized by the Captain of the Port Sector Ohio Valley or a designated representative.

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Rule 29 May 2025 regulatory compliance, healthcare, fda, medical devices, plazomicin

🩺FDA Classifies Plazomicin Test System as Class II Device

The Food and Drug Administration (FDA, Agency, or we) is classifying the plazomicin test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the plazomicin test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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Notice 29 May 2025 regulatory compliance, fda, debarment, health, drug importation

🚫FDA Issues Final Debarment Order Against Michael Dominic Diaz

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Michael Dominic Diaz for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Diaz was convicted of one felony count under Federal law. The factual basis supporting Mr. Diaz's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Diaz was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of May 16, 2024 (30 days after receipt of the notice), Mr. Diaz had not responded. Mr. Diaz's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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Notice 29 May 2025 regulatory compliance, washington, environmental assessment, ferc, hydroelectric, pacificorp

🌊Environmental Assessment for PacifiCorp Yale Hydroelectric Project

The Department of Energy's Federal Energy Regulatory Commission has released an Environmental Assessment for PacifiCorp's proposed modifications to the Yale Hydroelectric Project. The assessment evaluates the environmental effects of proposed changes, including dam improvements and potential public comments on these modifications. The findings indicate no major federal action with significant adverse effects on the environment.

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Notice 29 May 2025 regulatory compliance, energy, vermont, environmental assessment, hydroelectric

⚡Stowe Electric Department's Environmental Assessment Notice

The Town of Stowe Electric Department has filed for an exemption from licensing for the Smith's Falls Hydroelectric Project in Vermont. The Federal Energy Regulatory Commission intends to prepare an environmental assessment to evaluate the project's impacts. The process aims for meaningful public participation as comments will be considered in the final decision.

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Notice 29 May 2025 regulatory compliance, international trade, logistics, shipping agreements, maritime

🚢Notice of Shipping Agreements Impacting Business Operations

The Federal Maritime Commission announces the filing of agreements under the Shipping Act, including amendments that clarify cargo transport and expand geographic scope. Interested parties can submit comments on these agreements, which could influence operational strategies and partnerships in the shipping industry.

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Notice 29 May 2025 regulatory compliance, pharmaceuticals, fda, debarment, health, importation

🚫FDA Debarment Order

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Cole Henry for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Henry was convicted of a felony under Federal law for possession with intent to distribute a Schedule III controlled substance. The factual basis supporting Mr. Henry's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Henry was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of February 24, 2025 (30 days after receipt of the notice), Mr. Henry had not responded. Mr. Henry's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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Notice 29 May 2025 regulatory compliance, irs, business finance, tax reporting, form 1099-cap

📝IRS Invites Comments on Form 1099-CAP for Corporate Changes

In accordance with the Paperwork Reduction Act of 1995, the IRS is inviting comments on the information collection request outlined in this notice.

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Proposed Rule 29 May 2025 regulatory compliance, fda, food safety, pathogen contamination, sanitation programs

🍽️FDA Reopens Comment Period for Sanitation Guidance on Foods

The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry," which was announced in the Federal Register of January 7, 2025. We are taking this action in response to requests to allow interested persons additional time to submit comments before FDA begins work on the final guidance.

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Notice 29 May 2025 regulatory compliance, information collection, health and safety, labor, mine safety

⚠️Proposed Extension of Information Collection for Mine Safety

The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled Pattern of Violations.

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